Label: SUAVE HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 18, 2020

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  • Active ingredient

    Alcohol 80%

  • Purpose

    Antiseptic

  • Uses

    help decrease bacteria on the hands

  • Warnings

    For exteral use only

    Flammable. Keep away from fire or flame.

    Avoid contact with eyes, in case of contact, rinse eyes thoroughly with water immediately.

    If irritation develops, discontinue use and consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children except under adult supervision. If swallowed, get medical help or contact a poison control center right away.

  • Directions

    Wet hands thoroughly with product and rub lightly until dry. Do not wipe off or rinse.

  • Inactive ingredients

    Aminomethyl Propanol, Carbomer，Denatonium Benzoate, Purified Water USP

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Suave 500mL_Sinno

  • INGREDIENTS AND APPEARANCE
    SUAVE HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50069-106(NDC:75497-103)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50069-106-06236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    2NDC:50069-106-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/06/2020
    Labeler - UNILEVER ASIA PRIVATE LIMITED (894632699)
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